Results stable in 3-year extension of VIP trial for pathologic myopia

Visual acuity and contrast sensitivity remained stable over the 36-month follow-up. No additional safety concerns were identified.

Issue: December 15, 2002

MONTREUX, Switzerland – Patients undergoing photodynamic therapy with verteporfin for choroidal neovascularization due to pathologic myopia can rely on stable results and minimal complications for at least 3 years, according to the results of a 3-year extension of the Verteporfin in Photodynamic Therapy trial.

“The same 27 centers in the United States and Europe that participated in the original VIP trial contributed their patients to this extension. The aim of the study was to evaluate visual acuity, contrast sensitivity and safety in a selected group of myopic patients who continued the treatment for a further 12 months after the 2-year period of the original trial,” said Ursula Schmidt-Erfurth, MD, at the Club Jules Gonin meeting here.

Ninety-six of the 120 patients with pathologic myopia included in the VIP trial were enrolled in the extension study. Of those, 67 were previous verteporfin candidates and 29 were previous placebo candidates. Patients were allowed to participate in the extension study if verteporfin therapy was judged likely to reduce the risk of further vision loss associated with leakage from CNV. Median age was 51 years and median visual acuity was letter score 62 using Early Treatment Diabetic Retinopathy Study charts or Snellen 20/64.

Decreasing number of treatments

Most of the lesions (84%) were predominantly classic lesions, 13% were minimally classic lesions and 3% could not be graded. Two-thirds of the lesions were clearly subfoveal, while 14% were not. The remaining 20% were probably subfoveal based on angiographic readings. However, due to the intensive myopic degeneration signs, it was difficult to determine the exact position of the fovea, Prof. Schmidt Erfurth said.

A standard treatment protocol was used, and PDT was performed as often as every 3 months if fluorescein angiography showed leakage from CNV.

“If we look at the entire period of 36 months, we notice that the number of treatments tends to decrease over time. While during the first year patients received an average of 3.5 treatments, the treatment rate decreased to 1.9 during the second year and to only 0.4 during the last year in the study extension,” she said.

Patient attendance was good throughout the follow-up, with 59 patients available for the last visit at month 36. There was no protocol violation, only one withdrawal and one death, which was unrelated to the verteporfin treatment.

Stable visual results

Results of the original VIP trial showed that stable or improved vision had been achieved by 76% of patients at 12 months and by 66% at the end of the 2-year follow-up.

“During the third year there was nothing exciting going on. There was no loss or increase in those numbers. Patients who had stable vision after 2 years mostly kept their stable vision up to the end of the third year,” Prof. Schmidt-Erfurth said.

Moderate vision loss was defined as a loss of at least 15 letters or three lines.

“The end point that was reached after 24 months, which was 17% of patients who showed moderate vision loss, was almost the same after 3 years. There was a difference of only three patients,” she added.

In summary, 15% of patients had an increase in visual acuity and maintained it during the third year, and 73% maintained stable vision. Only a few patients lost some vision during the third year and 2% showed a vision increase during the third year.

Also, contrast sensitivity remained stable during the third year of the study.

“Patients who initially had low contrast sensitivity were treated late in the course of their disease, and there was nothing that could really be done. There was, however, no worsening with additional treatment,” she said.

No additional complications

There were no additional complications during the extension of the study. The patients originally assigned to verteporfin therapy had the same number of injection-related events and the same incidence of infusion-related back pain at 2 and 3 years. Photosensitivity reactions and visual disturbance were seen in 22% of the patients during the first 2 years and in 16% during the entire 3-year period.

“The exciting news is that there was no exciting news in our results,” Prof. Schmidt-Erfurth concluded. “Visual acuity remained stable in patients treated originally with verteporfin during the additional year and there were no safety concerns identified, particularly no cases of the acute severe vision decrease in visual acuity, defined as a loss of more than 20 letters, within a week of verteporfin therapy.”

For Your Information:
Ursula M. Schmidt-Erfurth, MD, can be reached at Augenklinik Der Univ., Ratzeburger Allee 160, Lübeck D-23538, Germany; (49) 451-500-2229; fax: (49) 451-500-3085. Dr. Schmidt-Erfurth is a patent holder on Visudyne. She is not a paid consultant for any companies mentioned.
Novartis Ophthalmics, distributor of Visudyne, can be reached at 11695 Johns Creek Pkwy, Duluth, GA 30097; (770) 905-1000; fax: (770) 905-1883.